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Regulatory Affairs Manager *PC Regulatory Affairs - Waltham MAAt Miltenyi Biotec, 3, employees worldwide develop pioneering solutions for biomedical science and the clinical application of cell therapies.
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I have a talented group of recruiters who specifically source Technical Sales Professionals, Scientists, Regulatory Affairs, Scientific Affairs, Executive Technical professionals, Quality Assurance, Product Development, Technical Service, Nutrition, Analytical and Corporate Chefs.
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The director will partner broadly with campus constituents such as but not limited to Development/Alumni Relations, LGBTQIA+ Center for Faculty & Staff, Residence Life/Housing, Student Activities, Howard Thurman Center for Common Ground, Student Health Services, Community & Inclusion, Government/Community Affairs, the Newbury Center, International Students and Scholars Office, and Athletics.
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Develop Standard Operating Procedures (SOPs) and Work Instructions (WIs) as directed by the Senior Director CMC Regulatory Affairs. They are seeking a Regulatory CMC Director or Associate Director who can develop CMC regulatory strategies and prepare CMC submissions for their clinical-stage small molecule drug programs and approved product.
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Work closely with individual clinical teams as well as functional area partners (e.g., Translational research, Precision Medicine and diagnostics, Regulatory Affairs, Market Access, Clinical Development) to identify and implement end-to-end Data Science solutions aimed at facilitating decision making.
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O Investigate and document reports of non-compliance involving laboratory animal care and use, including preparation and submission of reports and other documents to the IACUC, IO, and regulatory and accrediting agencies when indicated.
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Serves as the principal liaison to other MGB and Mass General hospital departments and services such as: Patient Care Services; Network Development; Marketing; Office of General Counsel; Development; Public Affairs and Communications; Research Management; Budget and Finance, etc.
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Bachelor's, Master's or PhD degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another life-science field. Similar Jobs (5) Director, Regulatory CMC, Cell & Gene Therapy (Boston) locations Boston, MA time type Full time posted on Posted 4 Days Ago External Manufacturing Associate Director (Person In Plant) - Cell & Gene Therapy locations Boston, MA time type Full time posted on Posted 30+ Days Ago Supply Chain Manager - Cell & Gene Therapy (Hybrid) locations Boston, MA time type Full time posted on Posted 25 Days Ago.
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The Senior Regulatory Affairs Specialist provides regulatory guidance to cross-functional teams; develops global regulatory strategies; advises on labeling and marketing materials for regulatory compliance; and evaluates product changes for impact on regulatory filings worldwide.
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The IACUC Regulatory Compliance Specialist has the overall responsibility for ensuring regulatory compliance within the areas of the animal care and use program that fall under the responsibility of the IACUC office.
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Within Global Regulatory Affairs, our Chemistry, Manufacturing and Controls (CMC) organization provides regulatory leadership to CMC development teams and the Pharma Supply Chain organization to enable approval of new medicines and uninterrupted supply of our medicines to patients.
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The Regional Medical Scientific Director (Medical Science Liaison) is a credentialed (i.e., PhD, PharmD, DNP, MD) Director Level Medical Affairs position and therapeutic and disease expert who engages in bidirectional exchange of scientific or medical information with Scientific Leaders (SLs.
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As part of the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. Leads the Early Development Pharmaceuticals GRA CMC regulatory team in the development and implementation of global CMC regulatory strategies during development ,commercialization and post approval LCM stages.
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Partner with the business and engage the HEMAR Global Market Access Team, Health Economics and Outcomes Research (HEOR) Team, and Clinical Affairs leaders to influence the short and long-term clinical and marketing plans to ensure the evidence needs of economic stakeholders are met for Philips products/solutions.
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Within SBS, the DA will work directly with the Department Chair, Associate Chair, Associate Director of Finance, Assistant Director of Operations and Finance and the Assistant Director of Academic Affairs.
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regulatory affairs jobs Title: regulatory affairs assistant Company: Philips in Boston, MA
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